Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00427999 | Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer | PHASE2 | COMPLETED | 67 | — | — | Feb 1, 2007 | Aug 1, 2015 | Nov 21, 2016 | 10 | Germany |
To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for \> 5 ng/ml.
| Arm | Type | Description |
|---|---|---|
| STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane | EXPERIMENTAL | STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks |
| Name | Type | Description |
|---|---|---|
| imatinib mesylate | DRUG | - |
| Treosulfane | DRUG | - |
| etoricoxib | DRUG | - |
| pioglitazone | DRUG | - |
| dexamethasone | DRUG | - |
Inclusion criteria: * Histologically confirmed prostate carcinoma, which has proven progression after primary hormone therapy (surgical or medicinal castration). * Patients must have increasing PSA levels (within 3 months prior to enrollment) with at least two consecutively increasing PSA levels. *...